NCT02537145

PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women

Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women - Pilot Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: W.J. Pasman · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The aim of this pilot study is to determine the feasibility of Do-It-Yourself studies in pregnant women to detect changes in health parameters by assessing compliance and user experiences of participants. Besides, the measured health will be analysed to increase insight in physiological development in pregnant women.

Detailed description

The study is designed as an open, parallel, do-it-yourself, explorative, two-group study. Subjects are women who are pregnant for approximately 3 months at the start of the study. Subjects will be included between week 12 and 15 of their pregnancy (T=-1). Week 16 is the start of the study (T=0). In the first group obese pregnant women (BMI ≥ 30) will be included; the second group will consist of lean pregnant women (BMI 18,5 - 25). The women will be requested to assess physiological parameters at regular intervals from three months pregnancy until giving birth (week 40). The assessment after giving birth, until three months after giving birth (total study duration of approximately nine months), is optional. Health parameters are known to be subject to change in pregnant women; the self-monitoring devices should be able to show these changes. Included subjects will be provided with the do-it-yourself devices, manuals and the study protocol. During the nine-month study, the subjects will use these do-it-yourself devices to self-monitor multiple health parameters in an at-home setting. They will be reminded to perform these tests via SMS. There are two frequency intervals defined (two week interval and eight week interval).

Conditions

• Pregnancy
• Obesity

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2015-09-01
• Last updated: 2018-09-06

Locations

1 site across 1 country: Netherlands